Z-0444-2019 Class II Terminated
FDA device recall Z-0444-2019 was initiated by Espiner Medical Ltd on June 20, 2018 and is designated Class II. Reason for recall: Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml The recall status is terminated (terminated December 9, 2019). Affected quantity: 230 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- June 20, 2018
- Termination Date
- December 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 230 units
Product Description
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
Reason for Recall
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Distribution Pattern
US Nationwide in the states of CA, IL, MT, NC, NJ,
Code Information
Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08